Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Global longitudinal strain to predict difficult separation from cardiopulmonary bypass

Official title: Global Longitudinal Strain as a Predictor of Difficult Separating From Cardiopulmonary Bypass

Run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital · NCT07390903 · Data updated 2026-11-12

This will test whether a heart ultrasound measure called global longitudinal strain (GLS) can predict which adults having elective cardiac surgery will have trouble coming off cardiopulmonary bypass.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment213 (estimated)
SponsorKartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Government
Locations2 sites (Rome and 1 other locations)
StatusRecruiting
StartedFebruary 5, 2026
Main results expectedJuly 30, 2026
Study endsAugust 30, 2026
Registry record updatedFebruary 5, 2026
Trial IDNCT07390903 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (over 18) scheduled for elective cardiac surgery requiring cardiopulmonary bypass who can give consent and do not have critical preoperative support or atrial fibrillation are ideal candidates.

Probably not a fit

Patients undergoing emergency or redo operations or those already on mechanical circulatory support, ongoing inotropes, mechanical ventilation, or with preoperative atrial fibrillation are excluded and unlikely to benefit from these GLS-based predictions.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational study will measure GLS by speckle-tracking echocardiography before and after elective cardiac surgery that uses cardiopulmonary bypass. Patients undergoing procedures such as isolated valve surgery, CABG, combined valve+CABG, or ascending aorta operations will have perioperative echocardiograms and routine postoperative monitoring. The study will compare preoperative GLS and perioperative changes with intraoperative difficulty separating from bypass and with outcomes including ICU stay, hospital length of stay, cardiac biomarkers, and 30-day mortality. Exclusions include emergency or redo surgery, active preoperative mechanical support, ongoing inotropes, mechanical ventilation, and preoperative atrial fibrillation.

Why it matters

Potential benefit: If successful, GLS could identify patients at higher risk of difficult CPB separation so teams can plan targeted monitoring and support to reduce complications.

How similar studies have gone: GLS has shown prognostic value in multiple cardiac conditions and small perioperative series suggest associations with outcomes, but large, definitive perioperative data are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria

* Age \> 18 years.
* Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB).
* Provided written informed consent to participate.
* Eligible surgical procedures include:

  * Isolated mitral valve replacement or repair.
  * Isolated aortic valve replacement or repair.
  * Isolated coronary artery bypass grafting (CABG).
  * Combined valve and CABG surgery.
  * Multiple valve replacement or repair.
  * Surgery involving the ascending aorta or aortic arch.

Exclusion Criteria

* Emergency cardiac surgery.
* Redo cardiac surgery.
* Contraindications to transesophageal echocardiography (TEE).
* Critical preoperative conditions, including:

  * Ongoing inotropic drug therapy.
  * Preoperative mechanical circulatory support (e.g., IABP, ECMO, VAD).
  * Requirement for mechanical ventilation.
  * Preoperative atrial fibrillation.

Where it's running

  • University of Rome Tor Vergata
    Rome, Italy
    Recruiting
  • Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
    Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.